Figure 1.Figure 1
CHAMPION-NMOSD trial design. The CHAMPION-NMOSD study is a Phase 3, open-label, externally placebo-controlled, multicenter trial designed to evaluate the efficacy and safety of ravulizumab in adult patients with AQP4-Ab+ NMOSD. Due to ethical concerns and the availability of eculizumab, a concurrent placebo group was not used; instead, the placebo group from the eculizumab Phase 3 trial, PREVENT, served as an external comparator. The study included four periods: screening, primary treatment, long-term extension, and safety follow-up, with the primary endpoint being the time to the first adjudicated on-trial relapse. a The end of the primary treatment period was to be triggered when two patients had an adjudicated on-trial relapse and all patients had completed, or discontinued before, 26 weeks on study. If two patients had not had an adjudicated on-trial relapse by the time all patients had completed, or discontinued before, 50 weeks on study, the end of the primary treatment period w